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1 for Prostate Cancer (DProstate Trial)

Phase 2
Waitlist Available
Led By Theo van der Kwast, MD, PhD, FRCPC
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of a Gleason score 6 or 7 adenocarcinoma of the prostate biopsy
Patient has elected to have a radical prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, final
Awards & highlights

DProstate Trial Summary

There is much interest in understanding the role that vitamin D3 (cholecalciferol) plays in various cancers, and in the prognosis of various cancers once they are discovered. The purpose of this study is to examine the effects of vitamin D on prostate cancer-associated lesions and on vitamin D metabolites in prostate tissue. We will give vitamin D3 to men when they are scheduled to have their prostate removed because of cancer. The men will take vitamin D at one of 3 doses for 4-6 weeks, until the surgery is performed. We will compare the prostate tissue taken from the men receiving the higher doses of vitamin D to tissue from men assigned to the lower doses. We expect to find that the prostate removed at surgery from men who received the high-dose vitamin D treatment will appear more normal, and less cancer like. In addition, we will measure vitamin D metabolites in the prostate to confirm that these did accumulate in the prostate to bring about the effects observed.

Eligible Conditions
  • Prostate Cancer

DProstate Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

DProstate Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end-of-study
This trial's timeline: 3 weeks for screening, Varies for treatment, and end-of-study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
immunohistochemical markers of prostate pathology
intraprostate vitamin D metabolites
Secondary outcome measures
calcium (serum and urine)
creatinine (serum and urine)
parathyroid hormone (PTH)
+3 more

DProstate Trial Design

3Treatment groups
Active Control
Group I: 1Active Control1 Intervention
vitamin D3 (400 IU/d)
Group II: 2Active Control1 Intervention
vitamin D3 (10,000 IU/d)
Group III: 3Active Control1 Intervention
vitamin D3 (40,000 IU/d)

Find a Location

Who is running the clinical trial?

Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,655 Total Patients Enrolled
7 Trials studying Prostate Cancer
7,535 Patients Enrolled for Prostate Cancer
Mount Sinai Hospital, CanadaOTHER
196 Previous Clinical Trials
67,518 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,550,532 Total Patients Enrolled
34 Trials studying Prostate Cancer
12,548 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Apr 2025